Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lun
This study is an open-label, multi-center, adaptive Phase 1/2 trial evaluating the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CAR-NK cell products in adults with relapsed or refractory small cell lung cancer (SCLC). Three candidate dual-target constructs (DLL3/CD56, DLL3/GD2, and
| Condition(s) | Small Cell Lung Cancer (SCLC), Relapsed/Refractory SCLC, SCLC, Extensive Stage |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This study is an open-label, multi-center, adaptive Phase 1/2 trial evaluating the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CAR-NK cell products in adults with relapsed or refractory small cell lung cancer (SCLC). Three candidate dual-target constructs (DLL3/CD56, DLL3/GD2, and CD56/GD2) will be assessed during dose escalation; a pre-specified interim assessment will select the most suitable construct to proceed into an expansion cohort at the recommended Phase 2 dose (RP2D). |
| Who can participate | Inclusion Criteria: * Age 18 to 75 years at the time of consent. * Histologically or cytologically confirmed small cell lung cancer (SCLC) that is metastatic, extensive-stage, or unresectable, and relapsed or refractory after at least 1 prior systemic regimen (must include a platinum-based regimen unless contraindicated). * At least one measurable lesion per RECIST v1.1. * ECOG performance status 0 to 1. * Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in the protocol (examples: ANC \>= 1.0 x10\^9/L, platelets \>= 75 x10\^9/L, creatinine clearance \>= 50 mL/min, AST/ALT \<= 3 x ULN, total bilirubin \<= 1.5 x ULN). * Life expectancy \>= 12 weeks. * Tumor tissue available (archival or fresh) for antigen profiling (DLL3, CD56/NCAM1, GD2). * Negative pregnancy te |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Beijing Biotech |
| Locations | Shenzhen, Guangdong, China |
| Start date | 2026-02-02 |
| NCT ID | NCT07480213 |
| Official listing | https://clinicaltrials.gov/study/NCT07480213 |